PDA Metro Chapter: Contamination Control Strategy
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The PDA Metro Chapter is pleased to announce this evening event featuring speaker Angel Salaman, PhD.
Abstract
The new version of EU GMP Annex 1 was issued in August, 2022, addressing the manufacture of sterile products. This version emphasis in the Contamination Control Strategy for sterile manufacturing and products and risk management tools. the purpose of this presentation is to introduce you to the CCS concept and explain an approach to develop the Contamination Control Strategy document for your process and products.
Speaker Bio
Dr. Angel Salaman is currently the Microbiology Lead of Lentiviral Virus Manufacturing at Raritan, NJ/Johnson and Johnson Microbiology Quality Control Laboratory of Microbial Quality and Sterility Assurance. With over 20 years' experience in sterile and non-sterile pharmaceutical manufacturing, Angel has high level experience in Environmental Monitoring (EM) Classified Rooms, Quality Systems, Analytical Microbial Methods verification/validation, Microbiology/manufacturing non-conformance investigations, Quality Risk Assessment and Process Excellence.
Event Location
225 Route 202, Basking Ridge, NJ Get DirectionsContact
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Day 1
- 5:15 pm - 6:15 pm | Registration Begins (Cash Bar, Food, and Vendor Booths will open
- 6:15 pm - 7:00 pm | Dinner
- 7:00 pm - 8:30 pm | Welcome, Seminar, Q&A and Closing Remarks
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